GSK Receives Order for H5N1 Antigen from US Government

August 9, 2007
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

GlaxoSmithKline reports that the US Department of Health and Human Services placed another order to purchase bulk H5N1 antigen for the US national stockpile of prepandemic vaccines.

Philadelphia (Aug. 3)-GlaxoSmithKline (GSK) reports that the US Department of Health and Human Services (HHS) placed another order to purchase bulk H5N1 antigen for the US national stockpile of prepandemic vaccines.

GSK received a second task order for 22.5 million doses of 15-µg H5N1 bulk vaccine antigen from HHS under contract HHS100200700027I, awarded in November 2007. This order is in addition to the 5 million doses of H5N1 clade 2 bulk antigen at 15 µg HA/dose ordered in November 2006. The new task order procures 9 million more doses of H5N1 clade 2 bulk vaccine produced in the 2006 manufacturing campaign and 13.5 million doses of H5N1 clade 2 bulk vaccine expected to be produced in the 2007 manufacturing campaign.

Under the terms of the contract, GSK will manufacture the bulk vaccine product at its manufacturing site in Ste. Foy, Canada, and store bulk H5N1 antigen at its site in Marietta, Pennsylvania. Terms of the contract also state that HHS may direct GSK to formulate this bulk antigen at some point in the future. HHS also has the option to purchase prepandemic vaccines together with one of GSK’s proprietary adjuvant systems, which could mean that less antigen would be needed per dose to achieve a protective immune response.

Funding for this contract is provided through the Office of Biomedical Advanced Research and Development Authority (BARDA) of the Assistant Secretary for Preparedness and Response (ASPR).

In other news, GSK also started its first prepandemic vaccine trials in North America involving its proprietary adjuvanted H5N1 vaccine. The vaccine used in these trials will be produced at the company’s manufacturing facility in Quebec, Canada. These US studies are supported by contract HHS100200700029C from BARDA, ASPR, and HHS, which was awarded in January 2007. The contract is for the advanced development of antigen-sparing pandemic influenza vaccines towards US licensure, with a commitment to US production of 150 million doses of pandemic vaccine within six months of a pandemic onset. GSK’s first North American prepandemic vaccine trial will be a Phase I–II study that evaluates its H5N1 antigen alone and in combination with one of its proprietary adjuvant systems. A Phase III Trial is expected for later in 2007.

In 2005, GSK invested approximately $2 billion in expanding its vaccine manufacturing and development activities in North America, primarily through the acquisition of the Canadian company ID Biomedical (IBD). GSK’s “FluLaval” and “Fluviral” seasonal influenza vaccines for use in North America and Canada are currently produced in IDB’s former facility in Quebec, Canada, and Dresden, Germany, respectively. GSK also is modernizing its Marietta facility to develop and manufacture cell-culture based seasonal and pandemic influenza vaccines. These cell culture vaccine candidates are not approved in the US.